510(k) K240319

DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040) by Pro Med Instruments GmbH — Product Code HBL

K240319 is an FDA 510(k) premarket notification submitted by Pro Med Instruments GmbH for the device "DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)". The FDA issued a decision of Substantially Equivalent on April 24, 2024. The device falls under product code HBL (Holder, Head, Neurosurgical (Skull Clamp)), a Class II device regulated under 21 CFR 882.4460. Pro Med Instruments GmbH has at least 5 other 510(k) clearances on record.